Extractables and Leachables of Biopharmaceutical Container Closure Systems: A Case Study by Pace Life Sciences (PLS)

Biopharmaceutical drug product development is on the rise, and with it new regulations on packaging and container closure components associated with delivery of the drug product to the patient. PLS scientists will discuss relevant USP and ISO guidelines and practical considerations when planning an extractables and leachables project.

PLS scientists will then present a case study demonstrating a typical extractables and leachables project, including the design, extraction, analysis and reporting of extractables and leachables data for typical single-use IV bags similar to those used for bioprocessing purposes.

In the webinar you will learn about the extractables and leachables program at PLS, and how to get started analyzing the materials for your next project.

Topics covered in this webinar:

• Results and analysis of an internal E&L case study of biopharmaceutical single use bag systems
• Overview of the process, procedures, and approaches for Biopharma E&L studies
• Analytical capabilities and expertise at Pace Life Sciences

Presenters:

Daniel Abate, Ph.D.
Principal Scientist 
Pace Analytical Life Sciences

Hannah Tims, Ph.D.
Principal Scientist 
Pace Analytical Life Sciences